FasterCures worked closely with Congress, federal agencies and the advocacy community throughout the legislation’s journey to the president’s desk. In February 2017, we debuted the 21st Century Cures Tracker to track the implementation of the 100+ sections in Division A, which include the key provisions relevant to biomedical research and innovation. (Other divisions of the law pertain to mental health and Medicare; since those are not areas of focus for FasterCures, we will not be actively tracking them here.) Learn more about how to use the tracker with our FAQs page.

A few examples of the issues we will be tracking include the impact of changes to the National Institutes of Health’s administrative requirements for grantees, how the Food and Drug Administration implements new changes designed to enhance patient engagement and how the Department of Health and Human Services is using its new authorities to promote health information technology interoperability.

Many external factors will affect the progress of these initiatives, including policies related to hiring freezes and uncertain funding levels. This tracker is not meant to be a pass/fail report card, but rather a snapshot in time that can help explain impact and identify where progress is needed.

Please keep coming back, as we will be updating the information regularly. Use the button below to send us feedback on the value of the information we are presenting, and the usability of this new resource.

8/22/2017: On August 21 & 22, 2017, Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) hosted it's first meeting and supplied full meeting materials for public consumption.

4/18/2017: the Federal Register published a meeting notice for the Task Force which will be August 21 & 22, 2017 and a second meeting will be November 6-7, 2017

3/21/2017: the NIH formally announced the establishment of the task force within the Eunice Kennedy Shriver National Institute of Child Health and Human Development. NICHD has reported to us that it is now in the process of compiling the slate of nominees to serve on the taskforce for the Secretary’s consideration.

12/13/2017: requires HHS issuance of guidance clarifying that remote access of health data by researchers (under appropriate circumstances) is not forbidden by regulation.
12/13/2017: requires HHS issuance of guidance clarifying requirements for the authorized disclosure of protected health information for research.
12/13/2017: requires HHS establishment of a "Working Group on Protected Health Information for Research" to study and, within 1 year of establishment, report on whether the uses and disclosures of protected health information for research purposes should be modified.
12/13/2017: requires submission of a report to the HHS Secretary

6/11/2017 (180 days): instructs FDA to develop a plan to issue draft and final versions of guidance documents regarding the collection of patient experience data, and the use of such data in drug development.
6/13/2018: requires FDA to issue a draft version of at least one such guidance identified in plan and within 18 months from close of public comment period, issue a final/ revised guidance.
12/13/2021: requires FDA to issued patient experience guidance documents

Requires FDA to periodically issue a report on FDA's use of patient experience data in regulatory decision-making, in particular with respect to the review of patient experience data and information on patient-focused drug development tools as part of approved applications.

12/13/2018: instructs FDA to convene a public meeting to solicit input on a new qualification process for biomarkers and other drug development tools.
12/13/2018: requires FDA to publish taxonomy on drug development tools for public comment. 1 year after close of comment period taxonomy must be finanlized.
12/13/2019: directs FDA to issue draft guidance on this qualification process.
12/13/2021: directs FDA to release a report which describes the use of, and success of, this new qualification process.

Permits FDA to allow the sponsor of a drug or biologic application for a genetically targeted drug or variant protein targeted drug to rely on data for the same or similar technology from previously approved applications developed by the same sponsor.

6/13/2018: directs FDA to host a public meeting to discuss the incorporation of complex adaptive and other novel trial designs into clinical protocols and new drug applications.

12/13/2019: requires FDA to issue draft guidance addressing the use of complex adaptive and other novel trial design in the development of new drugs or biologicals; within 1 year after the public comment period closes, FDA finalization of such guidance.

12/13/2017: instructs HHS to review regulations and guidance relevant to regenerative advanced therapies; and, through a public process, update such regulations and guidance as the Secretary determines appropriate.

Contains a number of elements designed to improve the regulation and review of combination products, including issuing guidance by 12/13/2020 that describes the process for managing pre-submission interactions, best practices for ensuring that feedback represents FDA's best advice, and information on meetings between the sponsor and FDA.

12/13/2017: requires FDA to issue guidance on the implementation of the medical device review pathway established by this provision.
1/1/2019: requires FDA to issue a report to Congress on the new medical device review pathway and opportunities for improvement.

6/13/2018: requires FDA to issue a guidance document define "probable benefit" in the context of the humanitarian device exemption.

6/7/2017: FDA rule notice in the Federal Register: section 3052 of the 21st Century Cures Act amended section 520(m) of the FD&C Act to allow for HDE approval for devices that, among other things, treat or diagnose a disease or condition that affects “not more than 8,000” individuals in the United States; this threshold had been “fewer than 4,000” individuals in the United States (amending 21 U.S.C. 360j(m), passim). This final rule amends part 814 (21 CFR part 814) in several places to accurately reflect the threshold recently enacted into law.

Requires FDA to provide an annual opportunity for stakeholders to provide recommendations for individuals with appropriate expertise to fill voting member positions on medical device classification panels

6/23/2017: FDA is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee and device panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health.

Removes the requirement that a sponsor of medical device trial use a local institutional review board. In effect upon enactment.

6/7/2017: On June 7, 2017 FDA rule notice in the Federal Register: “section 3056 of the 21st Century Cures Act amended section 520 of the FD&C Act to remove the requirement for institutional review committees, i.e., IRBs, for devices to be “local”, (amending 21 U.S.C. 360j, passim). This final rule amends 21 CFR 814.124(a), “IRB approval”, to remove the term “local” and related language in order to accurately reflect the requirements recently enacted into law.”

12/13/2018 (and every two years thereafter): requires HHS issuance of a report on the current state of health-related software and the regulation of those products.

12/8/2017: FDA announced the release of draft guidance entitled "Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act"; Submit either electronic or written comments on the draft guidance by February 6, 2018.

3/13/2017 (and every 5 years thereafter), instructs FDA to publish in the Federal Register a notice that contains Class II devices exempt from reporting requirements due to low risk; followed by 60 day public comment period. Final list published 7/11/2017.
4/12/2017 (and every 5 years thereafter): instructs FDA to provide a list of Class I devices exempt from reporting requirements due to low risk.

11/17/2017: FDA announced it received a petition requesting an exemption from the premarket notification requirements for over-the-counter (OTC) denture repair kits and is receiving comments.

4/13/2017: FDA issued a notice in the Federal Register identifying a list of class I devices that are now exempt from premarket notification requirements, subjects to certain eliminations. FDA's action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulation.

3/14/2017: FDA issued a notice in the Federal Register identifying more than 1,000 medical class II devices it is proposing to exempt or partially exempt from the premarket review process. A 60-day comment period is now open, after which FDA may narrow or expand this list.

12/13/2017: requires FDA establishment of at least one Intercenter Institute.

On January 19, 2017, Commissioner Califf announced the formation of the Oncology Center of Excellence and named Richard Pazdur as its director. The FDA allocated $3.6 million of existing agency funds to establish the OCE. However, a drafting error in sec. 1001(b)(3)(A) may prevent FDA from receiving an additional $75 million to fund the OCE. (Read more here and here).

12/13/2018: requires FDA to develop and begin to implement, a framework to evaluate the use of real world evidence to help support the approval a new indication for a for a previously approved drug, or to support post-approval study requirements.

12/13/2021: requires FDA to issue draft guidance based on implementation and use of RWE framework which describes circumstances where RWE may be relied upon and appropriate standards and methodologies for collection and analysis of RWE; by 18 months after the above comment period closes finalization of guidance.

7/31/2017: FDA announced a public workshop, "A Framework for Regulatory Use of Real-World Evidence” convened by the the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA. The purpose of the public workshop is to bring the stakeholder community together to discuss a variety of topics related to the use of real-world data (RWD) and real-world evidence (RWE) in drug development and regulatory decision making.

Creates a new pathway for FDA to approve antibacterial and antifungal drugs based for limited populations, using a benefit-risk profile specific to that population.
6/13/2018: requires FDA to issue draft guidance describing this pathway and related processes.
At least every 2 years, FDA must report to Congress on the applications and approvals under this program.
12/31/2021: requires GAO issuance of a report on this program.